Quality Site Head (Medical Devices)

Location: Aibonito, Puerto Rico

Salary: $168,000–$231,000 annually, plus potential discretionary bonuses, commissions, and/or long-term incentives.

Company

hirify.global develops healthcare products and solutions focused on saving and sustaining lives.

What you will do

• Lead governance, maintenance, and continuous improvement of the site Quality Management System.
• Serve as the site Quality Management Representative and ensure compliance with regulatory, customer, and company requirements.
• Prepare for and manage regulatory inspections and external audits.
• Set and monitor measurable quality objectives aligned with business priorities.
• Plan staffing, development, and budgeting for the site quality organization.
• Oversee product safety risk management, GMP compliance, quality documentation, product disposition, and management reviews.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline; an advanced degree is preferred.
• At least 10 years of experience in Quality, Manufacturing, or related functions within the medical device, pharmaceutical, or healthcare products industry.
• At least 7 years of progressive quality leadership experience, ideally in a global organization.
• Strong knowledge of FDA regulations, Quality Systems, Good Manufacturing Practices, and regulatory compliance.
• Experience leading quality organizations in complex manufacturing environments.
• Ability to manage multiple priorities, drive results through ambiguity, influence cross-functional stakeholders, and apply quality system methodologies.

Culture & Benefits

• Work is aligned with hirify.global’s mission to save and sustain lives, with quality prioritized over quantity when they conflict.
• Benefits include medical and dental coverage from day one, insurance programs, paid time off, holidays, family and medical leave, and paid parental leave for eligible roles.
• Financial benefits include an employee stock purchase plan and a 401(k) retirement savings plan with company matching options.
• Additional benefits include educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.
• US benefits listed in the posting exclude Puerto Rico; details should be confirmed with the recruiter.